Legal Authority For Irbs

The legal authority for IRBs derives from two parallel sets of federal regulations. One set of regulations was promulgated by the Department of Health and Human Services and implements the 1974 amendments to the Public Health Service Act (12). These regulations are codified in Title 45 of the Code of Federal Regulations (CFR), Part 46. The second set of regulations was promulgated by the FDA under the Federal Food, Drug, and Cosmetic Act (13). These regulations are codified in Title 21 of the CFR; regulations pertaining to IRBs are in Part 50 and those pertaining to informed consent are in Part 56.

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